Sterile surgical drape

ABSTRACT

An improved sterile drape, system, and method for draping portions of a telerobotic surgical system are provided. In one embodiment, a sterile drape includes an exterior surface adjacent to a sterile field for performing a surgical procedure, and an interior surface forming a cavity for receiving the non-sterile portion of a robotic surgical system, such as a manipulator. The drape further includes a fastener coupled to the exterior surface for securing the sterile drape to the non-sterile portion of the robotic surgical system while reducing the volume of the sterile drape. Advantageously, the drape allows for quick and simple installation and increases visualization of the patient by reducing the size of the drape with more form fitting features, while allowing for freedom of movement of the manipulator.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. patent applicationNo. 10/922,346, filed Aug. 19, 2004, now U.S. Pat. No. 7,357,774, whichis a continuation of U.S. patent application Ser. No. 10/004,399, filedOct. 30, 2001, now abandoned, which is a continuation of U.S. patentapplication Ser. No. 09/406,360, filed Sept. 28, 1999, now U.S. Pat. No.6,346,072, which is a continuation of U.S. patent application Ser. No.08/975,617, filed Nov. 21, 1997, now U.S. Pat. No. 6,132,368, the fulldisclosures of which are hereby incorporated by reference for allpurposes.

TECHNICAL FIELD

The present invention relates generally to surgical robot systems and,more particularly, to sterile drapes for covering portions of thesurgical robot system.

BACKGROUND

In robotically-assisted or telerobotic surgery, the surgeon typicallyoperates a master controller to remotely control the motion of surgicalinstruments at the surgical site from a location that may be remote fromthe patient (e.g., across the operating room, in a different room or acompletely different building from the patient). The master controllerusually includes one or more hand input devices, such as joysticks,exoskeletal gloves or the like, which are coupled to the surgicalinstruments with servo motors for articulating the instruments at thesurgical site. The servo motors are typically part of anelectromechanical device or surgical manipulator (“the slave”) thatsupports and controls the surgical instruments that have been introduceddirectly into an open surgical site or through trocar sleeves into abody cavity, such as the patient's abdomen. During the operation, thesurgical manipulator provides mechanical articulation and control of avariety of surgical instruments, such as tissue graspers, needledrivers, electrosurgical cautery probes, etc., that each perform variousfunctions for the surgeon, e.g., holding or driving a needle, grasping ablood vessel, or dissecting, cauterizing or coagulating tissue.

This new method of performing telerobotic surgery through remotemanipulation has, of course, created many new challenges. One suchchallenge results from the fact that a portion of the electromechanicalsurgical manipulator will be in direct contact with the surgicalinstruments, and will also be positioned adjacent the operation site.Accordingly, the surgical manipulator may become contaminated duringsurgery and is typically disposed of or sterilized between operations.From a cost perspective, it would be preferable to sterilize the device.However, the servo motors, sensors, encoders, and electrical connectionsthat are necessary to robotically control the motors typically cannot besterilized using conventional methods, e.g., steam, heat and pressure,or chemicals, because the system parts would be damaged or destroyed inthe sterilization process.

A sterile drape has been previously used to cover the surgicalmanipulator but the drape may at times be difficult or time-consuming toinstall, limit movement of the surgical manipulator, or hinder thesurgeon's view of the surgical site. Prior drapes have also at timeshindered visibility or touching of the monitor screen.

What is needed, therefore, are telerobotic systems, apparatus, andmethods for minimizing the need for sterilization to improve costefficiency while protecting the system and the surgical patient. Inaddition, these systems and methods should be designed to be simple toinstall and to minimize installation time while allowing for maximumfreedom of movement and visibility during the surgical procedure.Accordingly, a sterile drape, system, and method for robotic surgeryhaving improved efficiency and effectiveness are highly desirable.

SUMMARY

The present invention provides an improved sterile drape, system, andmethod for draping of portions of a telerobotic surgical system.

In accordance with an embodiment of the present invention, a steriledrape to cover a non-sterile portion of a robotic surgical system isprovided, the sterile drape including an exterior surface adjacent to asterile field for performing a surgical procedure, and an interiorsurface forming a cavity for receiving the non-sterile portion of therobotic surgical system. The drape further includes a fastener coupledto the exterior surface for securing the sterile drape to thenon-sterile portion of the robotic surgical system while reducing thevolume of the sterile drape.

In accordance with another embodiment of the present invention, arobotic surgical system for performing a procedure within a sterilefield is provided, the system including a manipulator arm, a monitor,and a sterile drape similar to that described above and including aninterior surface forming cavities for receiving the manipulator arm andthe monitor, and a plurality of fasteners for securing the sterile drapeto the manipulator arm and the monitor.

In accordance with yet another embodiment of the present invention, amethod of draping a robotic surgical system is provided, the methodincluding providing a sterile drape similar to that described above andincluding an open end with an integral cuff, positioning the open end ata portion of the robotic surgical system, holding the integral cuff tounfold the sterile drape over the portion of the robotic surgicalsystem, and securing the sterile drape to the portion of the roboticsurgical system using the fastener.

Advantageously, the present invention provides for improved installationof the drape and improved visibility of the surgical site and monitorwhile allowing for freedom of movement of the surgical manipulator.

The scope of the invention is defined by the claims, which areincorporated into this section by reference. A more completeunderstanding of embodiments of the present invention will be affordedto those skilled in the art, as well as a realization of additionaladvantages thereof, by a consideration of the following detaileddescription of one or more embodiments. Reference will be made to theappended sheets of drawings that will first be described briefly.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic view of an operating room, illustrating atelerobotic surgical system and method in accordance with an embodimentof the present invention.

FIG. 2 is an enlarged view of the operating room of FIG. 1 illustratinga pair of mounting joints coupled to an operating table according to thepresent invention.

FIG. 3A is a perspective view of a robotic surgical manipulator that ispartially covered by a sterile drape in accordance with an embodiment ofthe present invention.

FIG. 3B is a perspective view of the robotic surgical manipulator ofFIG. 3A without the sterile drape to illustrate a multiple degree offreedom arm coupling a driving assembly with a wrist unit and a surgicaltool.

FIG. 4 illustrates the robotic surgical manipulator of FIGS. 3A-3Bincorporating a camera and endoscope for viewing the surgical site.

FIG. 5 is a partial view of the robotic manipulator of FIGS. 3A-3B,illustrating mechanical and electrical couplings between the arm and thewrist unit.

FIG. 6 is a partially cut-away sectional view of a forearm and acarriage of the manipulator of FIGS. 3A and 3B.

FIG. 7 is a perspective view of the wrist unit in accordance with anembodiment of the present invention.

FIG. 8 is a side cross-sectional view of a portion of the roboticmanipulator, illustrating the arm and the drive assembly.

FIGS. 9A-9E are views of a monitor drape in accordance with anembodiment of the present invention.

FIGS. 10A-10J are views of an ECM (camera arm) drape in accordance withan embodiment of the present invention.

FIGS. 11A-11L are views of a PSM drape in accordance with an embodimentof the present invention.

Embodiments of the present invention and their advantages are bestunderstood by referring to the detailed description that follows. Itshould be appreciated that like reference numerals are used to identifylike elements illustrated in one or more of the figures. It should alsobe appreciated that the figures may not be necessarily drawn to scale.

DETAILED DESCRIPTION

The present invention provides a multi-component system and method forperforming robotically-assisted surgical procedures on a patient,particularly including open surgical procedures, neurosurgicalprocedures, such as stereotaxy, and endoscopic procedures, such aslaparoscopy, arthroscopy, thoracoscopy and the like. The system andmethod of the present invention is particularly useful as part of atelerobotic surgical system that allows the surgeon to manipulate thesurgical instruments through a servomechanism from a remote locationfrom the patient. To that end, the manipulator apparatus or slave of thepresent invention will usually be driven by a kinematically-equivalentmaster to form a telepresence system with force reflection. Adescription of a suitable slave-master system can be found in U.S.patent application Ser. No. 08/517,053, filed Aug. 21, 1995, thecomplete disclosure of which is incorporated herein by reference for allpurposes.

Referring to the drawings in detail, wherein like numerals indicate likeelements, a telerobotic surgical system 2 is illustrated according to anembodiment of the present invention. As shown in FIG. 1, teleroboticsystem 2 generally includes one or more surgical manipulator assemblies4 mounted to or near an operating table O, and a control assembly 6 forallowing the surgeon S to view the surgical site and to control themanipulator assemblies 4. The system 2 will also include one or moreviewing scope assemblies 19 and a plurality of surgical instrumentassemblies 20 adapted for being removably coupled to manipulatorassemblies 4 (discussed in detail below). Telerobotic system 2 usuallyincludes at least two manipulator assemblies 4 and preferably threemanipulator assemblies 4. The exact number of manipulator assemblies 4will depend on the surgical procedure and the space constraints withinthe operating room among other factors. As discussed in detail below,one of the assemblies 4 will typically operate a viewing scope assembly19 (e.g., in endoscopic procedures) for viewing the surgical site, whilethe other manipulator assemblies 4 operate surgical instruments 20 forperforming various procedures on the patient P.

Control assembly 6 may be located at a surgeon's console C which isusually located in the same room as operating table O so that thesurgeon may speak to his/her assistant(s) A and directly monitor theoperating procedure. However, it should be understood that the surgeon Scan be located in a different room or a completely different buildingfrom the patient P. Control assembly 6 generally includes a support 8, amonitor 10 for displaying an image of the surgical site to the surgeonS, and one or more controller(s) 12 for controlling manipulatorassemblies 4. Controller(s) 12 may include a variety of input devices,such as joysticks, gloves, trigger-guns, hand-operated controllers,voice recognition devices or the like. Preferably, controller(s) 12 willbe provided with the same degrees of freedom as the associated surgicalinstrument assemblies 20 to provide the surgeon with telepresence, orthe perception that the controller(s) 12 are integral with theinstruments 20 so that the surgeon has a strong sense of directlycontrolling instruments 20. Position, force, and tactile feedbacksensors (not shown) may also be employed on instrument assemblies 20 totransmit position, force, and tactile sensations from the surgicalinstrument back to the surgeon's hands as he/she operates thetelerobotic system. One suitable system and method for providingtelepresence to the operator is described in U.S. patent applicationSer. No. 08/517,053, filed Aug. 21, 1995, which has previously beenincorporated herein by reference.

Monitor 10 will be suitably coupled to the viewing scope assembly 19such that an image of the surgical site is provided adjacent thesurgeon's hands on surgeon console C. Preferably, monitor 10 willdisplay an inverted image on a display 18 that is oriented so that thesurgeon feels that he or she is actually looking directly down onto theoperating site. To that end, an image of the surgical instruments 20appears to be located substantially where the operator's hands arelocated even though the observation points (i.e., the endoscope orviewing camera) may not be from the point of view of the image. Inaddition, the real-time image is preferably transformed into aperspective image such that the operator can manipulate the end effectorand the hand control as if viewing the workspace in substantially truepresence. By true presence, it is meant that the presentation of animage is a true perspective image simulating the viewpoint of anoperator that is physically manipulating the surgical instruments 20.Thus, a controller (not shown) transforms the coordinates of thesurgical instruments 20 to a perceived position so that the perspectiveimage is the image that one would see if the camera or endoscope waslocated directly behind the surgical instruments 20. A suitablecoordinate transformation system for providing this virtual image isdescribed in U.S. patent application Ser. No. 08/239,086, filed May 5,1994, now U.S. Pat. No. 5,631,973, the complete disclosure of which isincorporated herein by reference for all purposes.

As shown in FIG. 1, a servomechanism 16 is provided for transferring themechanical motion of controllers 12 to manipulator assemblies 4.Servomechanism 16 may be separate from, or integral with manipulatorassemblies 4. Servomechanism 16 will usually provide force and torquefeedback from the surgical instruments 20 to the hand-operatedcontrollers 12. In addition, servomechanism 16 will include a safetymonitoring controller (not shown) that may freeze or at least inhibitall robot motion in response to recognized conditions (e.g., exertion ofexcessive force on the patient, “running away” of the manipulatorassemblies 4, etc.). The servomechanism preferably has a servo bandwidthwith a 3 dB cut off frequency of at least 10 hz so that the system canquickly and accurately respond to the rapid hand motions used by thesurgeon. To operate effectively with this system, manipulator assemblies4 have a relatively low inertia and the drive motors 170 (see FIG. 8)have relatively low ratio gear or pulley couplings. Any suitableconventional or specialized servomechanism may be used in the practiceof the present invention, with those incorporating force and torquefeedback being particularly preferred for telepresence operation of thesystem.

Referring to FIG. 7, surgical instrument assemblies 20 each include awrist unit 22 and a surgical tool 24 (FIGS. 3A and 3B) removablyattached to wrist unit 22. As discussed in detail below, each wrist unit22 generally includes an elongate shaft 56 having a proximal cap 58 anda distal wrist 60 pivotally coupled to surgical tool 24. Each wrist unit22 is substantially the same, and will have different or the samesurgical tools 24 attached thereto, depending on the requirements of thesurgical procedure. Alternatively, wrist units 22 may have specializedwrists 60 designed for individual surgical tools 24 so that the wristunits 22 may be used with conventional tools 24. As shown in FIG. 1, theinstrument assemblies 20 are usually assembled onto a table T or othersuitable support adjacent the operating table O. According to a methodof the present invention (described below), wrist units 22 and theirassociated surgical tools 24 can be quickly exchanged during thesurgical procedure by coupling and decoupling wrist unit shafts 56 frommanipulator assemblies 4.

Referring to FIG. 2, each manipulator assembly 4 is preferably mountedto operating table O by a mounting joint 30. Mounting joints 30 providea number of degrees of freedom (preferably at least 5) to assemblies 4,and they include a brake (not shown) so that assemblies 4 can be fixedat a suitable position and orientation relative to the patient. Joints30 are mounted to a receptacle 32 for mounting joints 30 to operatingtable O, and for connecting each manipulator assembly 4 toservomechanism 16. In addition, receptacle 32 may connect joints 30 toother systems, such as an RF electrical 2.0 power source, asuction-irrigation system, etc. Receptacle 32 includes a mounting arm 34that is slidably disposed along an outer rail 36 of operating table O.Manipulator assemblies 4 may also be positioned over the operating tableO with other mechanisms. For example, the system may incorporate asupport system (coupled to the ceiling or a wall of the operating room)that moves and holds one or more manipulator assemblies 4 over thepatient.

Referring now to FIGS. 3-8, manipulator assembly 4 will be described infurther detail. Manipulator assembly 4 is a three-component apparatusthat includes a non-sterile drive and control component, a sterilizableend effector or surgical tool (i.e., surgical instrument assembly 20),and an intermediate connector component. The intermediate connectorincludes mechanical elements for coupling the surgical tool 24 with thedrive and control component, and for transferring motion from the drivecomponent to the surgical tool 24. As shown in FIG. 3B, the drive andcontrol component generally includes a drive assembly 40 and a multipledegree of freedom robotic arm 42 coupled to a mounting bracket 44, whichis adapted for mounting onto mounting joints 30 (FIG. 2). Preferably,drive assembly 40 and robotic arm 42 are pivotally coupled to bracket 44about an X-axis, which extends through a remote center of sphericalrotation 45 (see FIG. 8, discussed in further detail below). Manipulatorassembly 4 further includes a forearm assembly 46 fixed to a distal end48 of arm 42, and a wrist unit adaptor 52 coupled to forearm assembly 46for mounting wrist unit 22 and surgical tool 24 to manipulator assembly4.

For endoscopic procedures, manipulator assembly 4 additionally includesa cannula adaptor 64 attached to a lower portion of forearm 46 formounting a cannula 66 to manipulator assembly 4. Alternatively, cannula66 may be an integral cannula (not shown) that is built into forearmassembly 46 (i.e., non-removable). Cannula 66 may include a forcesensing element (not shown), such as a strain gauge or force-sensingresistor, mounted to an annular bearing within cannula 66. The forcesensing bearing supports surgical tool 24 during surgery, allowing thetool to rotate and move axially through the central bore of the bearing.In addition, the bearing transmits lateral forces exerted by thesurgical tool 24 to the force sensing element, which is connected toservomechanism 16 for transmitting these forces to controller(s) 12. Inthis manner, forces acting on surgical tools 24 can be detected withoutdisturbances from forces acting on cannula 66, such as the tissuesurrounding the surgical incision, or by gravity and inertial forcesacting on manipulator assembly 4. This facilitates the use ofmanipulator assembly 4 in a robotic system because the surgeon willdirectly sense the forces acting against the surgical tool 24.

As shown in FIG. 3A, manipulator assembly 4 further includes a steriledrape 70 sized to cover substantially the entire manipulator assembly 4.Drape 70 has a pair of holes 72, 74 sized and arranged so that wristunit adaptor 52 and cannula adaptor 64 may extend through holes 72, 74to mount wrist unit 22 and cannula 66 to manipulator assembly 4. Steriledrape 70 comprises a material configured to effectively shieldmanipulator assembly 4 from the surgical site so that most of thecomponents of assembly 4 (i.e., arm 42, drive assembly 40 and forearmassembly 46) do not have to be sterilized prior to, or following thesurgical procedure.

As shown in FIG. 3A, wrist unit adaptor 52 and cannula adaptor 64 extendthrough holes 72, 74 of drape 70 so that forearm assembly 46 and theremainder of manipulator assembly 4 remain shielded from the patientduring the procedure. In one embodiment, wrist unit adaptor 52 andcannula adaptor 64 are manufactured as reusable components that will besterilized because these components extend into the sterile field of thesurgical site. Wrist unit and cannula adapters 52, 64 may be sterilizedby normal methods, i.e., steam, heat and pressure, chemicals and thelike. Referring again to FIG. 3B, wrist unit adaptor 52 includes anopening 80 for receiving shaft 56 of wrist unit 22. As discussed indetail below, shaft 56 can be laterally urged through opening 80 andsnap-fit into adaptor 52 such that the non-exposed portion of wrist unitadaptor 52 remains sterile (i.e., remains on the sterile side of drape70 opposite the sterile field). Wrist unit adaptor 52 may also include alatch (not shown) for securing wrist unit 22 therein. Similarly, cannulaadaptor 64 includes an opening 82 for snap fitting cannula 66 theretosuch that the non-exposed portion of adaptor 64 remains sterile duringthe surgical procedure.

As shown in FIG. 4, wrist unit adaptor 52 may also be configured toreceive a viewing scope 100 for viewing the surgical site. Forendoscopic procedures, viewing scope 100 can be a conventionalendoscope, which typically includes a rigid, elongated tube 102containing a lens system (not shown) and a camera mount 104 at theproximal end of the tube 102. A small video camera 106 is preferablyattached to the camera mount 104 and connected to video monitor 10 toprovide a video image of the procedure. Preferably, the scope 100 has adistal end (not shown) configured to allow lateral or angled viewingrelative to tube 102. The viewing scope may also have a guidable tipthat can be deflected or rotated by manipulating an actuator on aproximal end of tube 102. This type of scope is commercially availablefrom Baxter Healthcare Corp. of Deerfield, Ill., or Origin Medsystems,Inc. of Menlo Park, Calif.

As shown in FIG. 4, viewing scope 100 further includes a scope adaptor110 for coupling viewing scope 100 to wrist unit adaptor 52. Scopeadaptor 110 is sterilizable, ETO and autoclavable, and it includes aplurality of motion feed-throughs (not shown) for transferring motionfrom drive assembly 40 to scope 100. In the preferred configuration, themotion includes pitch and yaw motion, rotation about the Z-axis, andmovement along the Z-axis.

Referring now to FIGS. 5 and 6, forearm assembly 46 will be described infurther detail. As shown in FIG. 5, forearm assembly 46 includes ahousing 120 fixed to arm 42 and a movable carriage 122 slidably coupledto housing 120. Carriage 122 slidably mounts wrist unit adaptor 52 tohousing 120 for moving wrist unit adaptor 52 and wrist unit 20 in theZ-direction. In addition, carriage 122 defines a number of openings 123for transferring motion and electrical signals from forearm assembly 46to wrist unit adaptor 52. As shown in FIG. 6, a plurality of rotatableshafts 124 are mounted within housing 120 for transferring motion fromarm 42 through openings 123 to wrist unit adaptor 52 and wrist unit 22.Rotating shafts 124 preferably provide at least four degrees of freedomto wrist unit 22, including yaw and pitch motion of surgical tool 24about wrist 60 of wrist unit 22, rotation of wrist unit 22 about theZ-axis and actuation of tool 24. The system may also be configured toprovide more or less degrees of freedom, if desired. Actuation of tool24 may include a variety of motions, such as opening and closing jaws,graspers or scissors, applying clips or staples and the like. Motion ofwrist unit 22 and tool 24 in the Z direction is provided by a pair ofcarriage cable drives 126 extending between rotatable pulleys 128, 129on either end of forearm housing 120. Cable drives 126 function to movecarriage 122 and wrist unit 22 in the Z direction relative to forearmhousing 120.

As shown in FIG. 6, distal end 48 of arm 42 includes a coupling assembly130 having a plurality of motion feed-throughs 132 for transferringmotion from arm 42 to forearm assembly 46. In addition, couplingassembly 130 includes a number of electrical connectors (not shown) fortransferring electrical signals from arm 42 to wrist unit 22. Similarly,wrist unit adaptor 52 includes a plurality of motion feed-throughs (notshown) and electrical connections (not shown) for transferring motion,and for sending and receiving electrical signals to and from wrist unit22 (e.g., for sending and receiving force and torque feedback signalsfrom the surgical site to controllers 12). The components on either sideof coupling assembly 130 and wrist unit adaptor 52 have a finite rangeof motion. Usually, this range of motion will be at least 1 revolutionand preferably greater than 1 revolution. These ranges of motion arealigned with each other when the forearm assembly 46 is mechanicallycoupled to the coupling assembly 130 and when wrist unit adaptor 52 ismechanically coupled to the forearm 46.

Referring to FIG. 7, wrist unit 22 will now be described in furtherdetail. As shown, wrist unit 22 includes a hollow shaft 56 having a cap58 attached to its proximal end and a wrist 60 attached to its distalend. Wrist 60 includes a coupling (not shown) for removably coupling avariety of surgical tools 24 to shaft 56. Shaft 56 is rotatably coupledto cap 58 for providing rotation of shaft 56 and tool 24 about thelongitudinal axis of shaft 56 (i.e., the Z axis). Cap 58 houses amechanism (not shown) for transferring motion from wrist unit adaptor 52to drive cables (not shown) within shaft 56. The drive cables aresuitably coupled to drive pulleys within shaft 56 to pivot tool 24 aboutwrist 60, and to actuate end effectors 140 on tool 24. Wrist 60 may alsobe operated by other mechanisms, such as differential gears, push-rods,or the like.

Tool 24 is removably coupled to wrist 60 of wrist unit 22. Tool 24 willpreferably include an end effector 65 (FIGS. 3A and 3B) having a tactilesensor array (not shown) for providing tactile feedback to the surgeon.Tool 24 may include a variety of articulated tools, such as jaws,scissors, graspers, needle holders, micro dissectors, staple appliers,tackers, suction irrigation tools, clip appliers, that have endeffectors driven by wire links, eccentric cams, push-rods or othermechanisms. In addition, tool 24 may comprise a non-articulatedinstrument, such as cutting blades, probes, irrigators, catheters orsuction orifices. Alternatively, tool 24 may comprise an electrosurgicalprobe for ablating, resecting, cutting or coagulating tissue. In thelatter embodiment, wrist unit 22 will include a conductive element, suchas a proximal banana plug coupled to a lead wire or rod extendingthrough shaft 56 to tool 24.

Referring to FIGS. 4 and 8, a specific configuration of the drive andcontrol component of the present invention (i.e., the robotic arm 42 anddrive assembly 40) will be described in further detail. As discussedabove, arm 42 and drive assembly 40 are rotatably coupled about a pairof pins 150 extending from mounting bracket 44. Arm 42 preferablycomprises an elongate, substantially rigid body 152 with a distal end 48coupled to forearm assembly 48 and a proximal end 154 pivotally coupledto drive assembly 40 and bracket 44 for rotation about pitch and yaw orthe X and Y axes (note that the Y axis is perpendicular to the page andextends through point 45, see FIG. 8). Arm 40 may have otherconfigurations, such as an elbow arm (similar to the human arm),prismatic arm (straight extendable) or the like. A stationary yaw motor156 is mounted to mounting bracket 44 for rotating arm 42 and driveassembly 40 about the X-axis. Drive assembly 40 also includes a pitchmotor 158 coupled to arm 42 for rotating arm about the Y axis. A pair ofsubstantially rigid linkage elements 160, 124 extend from bracket 44 torobotic arm 42 to pivotally couple arm 42 to bracket 44 about Y-axis.One of the linkage elements 160 is pivotally coupled to arm 42, and theother linkage element 124 is pivotally coupled to a third linkageelement 164 extending parallel to arm 42. Preferably, robotic arm 42 isa channel shaped rigid element that at least partially houses the thirdlinkage element 164. The linkage elements 160, 124 and 164 and arm 42form a parallelogram linkage in which the members are connected togetherin a parallelogram for relative movement only in the plane formed by themembers.

The Z-axis of wrist unit 22 held at the distal end 48 of arm 42intersects the x axis of the parallelogram linkage described above.Wrist unit 22 has a remote center of spherical rotation about theposition indicated by the numeral 45 in FIG. 8. Thus, the distal end ofwrist unit 22 can be rotated about its own axis or the X and Y axeswhile the remote center of rotation 45 remains at the same location. Amore complete description of a remote center positioning device can befound in U.S. patent application Ser. No. 08/504,301, filed Jul. 20,1995, now U.S. Pat. No. 5,931,832, the complete disclosure of which isincorporated herein by reference for all purposes. It should be notedthat arm 42 and drive assembly 40 may be used with a broad range ofpositioning devices other than that described above and shown in FIG. 8,such as a stereotaxic positioner, a fixed gimbal, or the like.

Referring again to FIG. 8, drive assembly 40 further includes aplurality of drive motors 170 coupled to arm 42 for rotation therewith.Pitch and yaw motors 156, 158 control the motion of arm 42 (and drivemotors 170) about the X and Y axes and drive motors 170 control themotion of wrist unit 22 and surgical tool 24. Preferably, at least fivedrive motors 170 are coupled to arm 42 for providing at least fivedegrees of freedom to wrist unit 22. Drive motors 170 will preferablyinclude encoders (not shown) for responding to servomechanism 16 andforce sensors (not shown) for transmitting force and torque feedback tothe surgeon S. As discussed above, the five degrees of freedompreferably include movement of carriage 122 and wrist unit 22 in theZ-direction, rotation of wrist unit 22 about the Z-axis, pitch and yawrotation of surgical tool 24 around wrist 60 and actuation of tool 24.

As shown, cables 172 extend from each motor 170 around a motor drivepulley 174, an idler pulley 176 within arm 42 and along a relativelylarge pot capstan 178 to minimize the effect of friction torque oncables 172. The cables 172 each extend around another idler pulley 180at distal end 48 of arm 42, around a coupling drive pulley 182 and backto the motor 170. The cables 172 will preferably be tensioned at themotor drive pulley 174 and anchored there as well as at the couplingdrive pulley 182. As shown in FIG. 8, coupling drive pulley 182 isconnected to a plurality of smaller pulleys 184 within coupling assembly130 via a plurality of cables 186 for transferring motion from themotors 170 to wrist unit adaptor 52.

A method for performing a surgical procedure on a patient according tothe present invention will now be described with reference to FIGS. 1-8.As shown in FIG. 2, mounting joints 30 are attached to receptacle 32,which is attached to the operating table O by sliding mounting arm 34along rail 36. Each manipulator assembly 4 is then attached to itsrespective mounting joint 30 and articulated into the proper positionand orientation relative to the patient P. Receptacles 32 are thencoupled to servomechanism 16 and other systems that may be requiredduring the surgical procedure, such as an RF power supply, asuction/irrigation system, etc. Sterile drapes 70 are placed over themanipulator assemblies 4 before, during, or after the patient has beenanesthetized (FIG. 3A). To prepare for the surgical procedure,manipulator assemblies 4 may or may not be chemically cleaned prior tocovering them with drapes 70. Wrist unit adapters 52, cannula adapters64, and scope adapters 110 are snapped onto forearm assemblies 46 ofmanipulator assemblies 4 (see FIGS. 3B and 5). The number and relativepositions of scope adapters 110 and wrist unit adapters 52 will, ofcourse, depend on the individual surgical procedure (e.g., cannulaadapters 64 may not be required for open surgical procedures).

During the surgical procedure, surgical instrument assemblies 20 arecoupled to their respective manipulator assemblies 4 by laterally urgingeach respective wrist unit shaft 56 through opening 80 of wrist unitadaptor 52. Each wrist unit 22 will have suitable identification means(not shown) to quickly and easily indicate what type of tool 24 isconnected to the wrist unit 22. When the surgeon wishes to changesurgical tools 24, he or she manipulates controller(s) 12 so thatcarriage 122 moves to a top or proximal position of travel along forearmassembly 46 (see FIG. 3B). In this position, surgical tool 24 is withincannula 66 or during open procedures, removed from the surgical site.The assistant(s) A then pulls upward on wrist cap 58 to release thelatch (not shown), thereby allowing wrist unit 22 to slide furtherupwards and out of cannula 66. The assistant(s) A may then pull wristunit 22 laterally to decouple it from wrist unit adaptor 52. When wristunit 22 is no longer coupled to adaptor 52, the control mechanismunderstands that the system is in “tool change mode”, and drivescarriage 122 to the proximal position if it has not already been movedthere by the surgeon.

To couple another surgical instrument assembly 20 to manipulatorassembly 4, the assistant(s) A grabs another assembly 20 from table T,laterally urges wrist unit shaft 56 into opening 80 of wrist unitadaptor 52, and then moves wrist unit 22 downward so that surgical tool24 resides within cannula 66 (see FIGS. 1 and 3B). This downwardmovement of wrist unit 22 automatically mates the electrical couplingsand motion feed-throughs (not shown) within wrist cap 58 and wrist unitadaptor 52. The system may include a control mechanism configured tolock carriage 122 travel at the top or proximal position, e.g., byactuating a brake (not shown), until the couplings are mated and wristunit 22 is no longer being moved downward. At this point, the surgeon Smay continue the surgical procedure.

The system and method of the present invention preferably includes amechanism for counting the number of times wrist unit 22 is decoupledand coupled from wrist unit adaptor 52. In this manner, the manufacturermay limit the number of times wrist unit 22 can be used. In a specificconfiguration, an integrated circuit chip (not shown) is housed withinwrist cap 58. The circuit chip counts the number of times wrist unit 22is coupled to wrist unit adaptor 52, e.g., 20 times, and a warning showsup on the surgeon's console C. The control system then downgrades theperformance of the system by reducing the load it can deliver orincreasing apparent backlash.

Referring now to FIGS. 9A-9E, a monitor drape package 200 including amonitor drape 204 that is part of sterile drape 70 (described above withreference to FIG. 3A) is shown. Monitor drape 204 may be a connected ordisconnected section of sterile drape 70. FIG. 9A shows monitor drapepackage 200 including a monitor drape pouch 202 with monitor drape 204folded inside. Monitor drape 204 is a disposable sterile drape assemblywhich is placed over a monitor and monitor mount to maintain a sterilebarrier between the monitor/monitor mount and the sterile field of thesurgical procedure. Advantageously, various features of the monitordrape aid the draping and installation process.

FIG. 9B shows monitor drape 204 removed from pouch 202 with drape 204including a touch screen window 206 to be placed adjacent to the screenof a monitor (e.g., monitor 10 of FIG. 1). Touch screen window 206 isbetween two flaps 208 of monitor drape 204 and is not folded to reducecreases and increase adhesion to the monitor screen. In one example,touch screen window 206 is a clear, static-cling window to be positionedin front of the monitor screen. The clear window allows the user to seeand use a touch screen monitor while maintaining a sterile barrier.Window 206 has a static charge which maintains a static cling functionallowing window 206 to sit flat against the monitor screen to reducereflections and glare and to keep the window secure for touch screenusage.

FIG. 9C shows monitor drape 204 with flaps 208 unfolded. As previouslynoted, monitor drape 204 is folded in a way to assure that the screenwindow section is not folded, thereby reducing creases in the materialand allowing flatter positioning on the monitor screen.

FIG. 9D shows four loop fasteners 212, two vents 214, a strap 216, apermanent cuff 220, a blue tape 218 on the edge of cuff 220, and a pursestring 222 built into cuff 220. Loop fasteners 212 are included oneither side of screen window 206 on the inside of the drape. Loopfasteners 212 include strips of Velcro which mate with hook fasteners(not shown) located on the back of the monitor mount. These hook andloop fasteners allow the user to quickly pull the drape taught and fixedin position in front of the monitor screen. Vents 214 allow heatgenerated by the monitor to vent from monitor drape 204. The vents areabove and below the monitor area to allow for convection heat venting.Vents 214 also allow for the transmission of sound from the sterilefield to a microphone installed proximate the monitor. Straps 216 helpcontrol drape 204 and reduce the visual size of the drape (i.e., reducethe volume of or space taken up by the unfolded drape). Blue tape 218acts as a physical marker on the drape to designate the sterile andnon-sterile ends. By having blue tape 218 act as a marker, a non-sterileperson can know to pull on the non-sterile side if assisting the sterilescrub nurse. Purse string 222 allows the user to pull monitor drape 204tight around the monitor mount at the end of the drape.

FIG. 9E shows an enlarged view of the drape area proximate cuff 220,including a tear strip 224. Cuff 220 is integral to the end of thedrape. A sterile scrub nurse may place his or her hands into these cuffswhen pulling the drape over the monitor. By having a cuff, the user isassured that their hands are not touching something that is non-sterileas they work their way along the monitor. Tear strips 224 are used tocontrol unfolding of the drape during installation. Tear strips 224 holdthe drape in its folded position (as shown for example in FIG. 9C), andas the user installs the drape, tear strips 224 are broken as the drapeis pulled back over the monitor.

Referring now to FIGS. 10A-10J, an endoscope camera manipulator (ECM)(camera arm) drape package 300 including an ECM drape 304 that is partof sterile drape 70 (described above with reference to FIG. 3A) isshown. ECM drape 304 may be a connected or disconnected section ofsterile drape 70. FIG. 10A shows ECM drape package 300 including an ECMdrape pouch 302 with ECM drape 304 folded inside. The ECM drape is adisposable sterile drape assembly designed to establish a sterilebarrier between the non-sterile ECM camera arm and the sterile field ofthe surgical procedure. Advantageously, various features of ECM drape304 aid the draping and installation process.

FIG. 10B shows ECM drape 304 removed from pouch 302. ECM drape 304 isfolded with two flaps 308 and arrow labels show the direction forunfolding of flaps 308. FIG. 10C shows ECM drape 304 with flaps 308unfolded. FIG. 10D shows visual indicators 310 for positioning orlocating ECM drape 304 on the ECM arm. Visual indicators 310 include apatch 312 and a patch 314 as described in more detail below with respectto FIG. 10F. FIG. 10E shows a closed end of ECM drape 304 partiallyunfolded. FIG. 10F shows a reinforcement patch 312 used to keep ECMdrape 304 from interfering when installing a camera on the ECM arm. Alsoshown is a peel-and-stick patch 314 for attaching a camera sterileadaptor.

FIG. 10G shows tear strips 316 that define the main entrance/exit of thedrape through which the ECM arm enters or exits ECM drape 304. ECM drape304 is packaged such that the folded drape can be first placed over theECM arm. The drape is set in this initial position by using tear strips316 which allow for the controlled unfolding of the drape by tearingwhen pulled on with the necessary force. The user pulls ECM drape 304along the length of the ECM arm by placing their hands in cuffs 323(FIG. 10I) and pulling the drape along the ECM arm. FIG. 10H shows ECMdrape 304 fully unfolded.

FIG. 10I shows a strap 318 at the end of ECM drape 304, a blue tape 320at the edge of a cuff 323, a slit 322 in cuff 323 for wrapping the ECMdrape around the monitor mount, and peel-and-stick patches 314. ECMdrape 304 includes an integral cuff 323 at the end of the drape. Thesterile scrub nurse may place his or her hands into these cuffs whenpulling the drape along the ECM arm, thereby assuring the user thattheir hands are not touching something that is non-sterile as they worktheir way along the ECM arm. Blue tape 320 acts as a physical marker onthe drape to designate the sterile and non-sterile ends. By having bluetape 320 act as a marker, a non-sterile person can know to pull on thenon-sterile side if assisting the sterile scrub nurse.

FIG. 10J shows straps 318 which help to control the ECM drape and reducethe visual size of the drape (i.e., reduce the volume of or space takenup by the unfolded drape). There is one strap proximate the cannulamount area, another strap proximate a “link 3” of the ECM arm, andanother strap proximate the “setup arm” (e.g., arm 42 of FIGS. 4 and 5)onto which the ECM arm is mounted.

Referring now to FIGS. 11A-11M, a patient side manipulator (PSM) drapepackage 400 including a PSM drape 404 that is part of sterile drape 70(described above with reference to FIG. 3A) is shown. PSM drape 404 maybe a connected or disconnected section of sterile drape 70. FIG. 11Ashows PSM drape package 400 including a PSM drape pouch 402 with PSMdrape 404 folded inside. The PSM drape is designed to establish asterile barrier between the non-sterile PSM arms and the sterile fieldof the surgical procedure. PSM drape 404 includes an integral instrumentsterile adaptor (ISA) permanently mounted on the drape, with thecomplete assembly including the ISA, which is used to engage a surgicaltool. Embodiments of applicable adaptors, tools, or accessories aredescribed for example in U.S. Pat. Nos. 6,331,181, 6,491,701, and6,770,081, the full disclosures of which (including disclosuresincorporated by reference therein) are incorporated by reference hereinfor all purposes. Thus, the drape is completely disposable in oneembodiment. Advantageously, various features of the PSM drape aid thedraping and installation process.

FIG. 11B shows PSM drape 404 removed from pouch 402. FIG. 11C shows anexample of a sterile adaptor 406 permanently mounted to PSM drape 404proximate a closed end of PSM drape 404. FIG. 11D shows tear strips 408that define the main hole in the folded PSM drape and folded flaps 410.FIG. 11E shows flaps 410 unfolded, and FIG. 11F shows PSM drape 404completely unfolded. PSM drape 404 is packaged so that the folded drapecan be first placed over the PSM arm and then the permanently mountedsterile adaptor 406 is attached to the PSM arm by first locating a fronttongue feature into a bracket on the PSM arm followed by swinging theother end of the sterile adaptor until it engages a latch on the PSMarm. PSM drape 404 is maintained in this initial position by using tearstrips 408 which allow for the controlled unfolding of the drape bytearing when pulled on with the necessary force. The user pulls thedrape along the length of the PSM arm by placing their hands in integralcuffs 412 (FIG. 11G) and pulling the drape along the PSM arm.

FIGS. 11G1 and 11G2 show an integral cuff 412 at the open end of PSMdrape 404, the edge of cuff 412 including a blue tape 411. The sterilescrub nurse may place his or her hands into the cuff when pulling thePSM drape along the PSM arm, and by using the cuff, the user is assuredthat their hands are not touching something that is non-sterile as theywork their way along the PSM arm. Blue tape 411 acts as a physicalmarker on the drape to designate the sterile and non-sterile ends. Byhaving this marker, a non-sterile person can know to pull on thenon-sterile side when assisting the sterile scrub nurse.

FIG. 11H shows straps 414 on the drape to help control the drape andreduce the visual size of the drape (i.e., reduce the volume of or spacetaken up by the unfolded drape). One strap is proximate the cannulamount area, another strap is proximate a “link 3” of the PSM arm, andanother strap is along a “setup arm” (e.g., arm 42 of FIGS. 4 and 5)onto which the PSM arm is mounted.

FIG. 11I shows strips 416 along the insertion axis and a cannula mountpouch 418. A cannula mount pouch that may be used is disclosed inco-pending U.S. patent application Ser. No. 11/240,087, filed Sept. 30,2005, the contents of which is incorporated by reference herein for allpurposes. Strips 416 are malleable strips on the drape in an insertionaxis area. Strips 416 are attached to the drape between the sterileadaptor and the cannula mount area. Once the drape is installed on thePSM arm, the user can deform the malleable strips 416 to help fold backexcess drape material. By being able to fold back and secure excessdrape material, the drape can be made to closely fit the shape of thePSM arm. Advantageously, this reduces the visual size of the system andthereby allows more visibility of the patient and their surroundings tothe surgeon or other user(s). Strips 416 are also sufficiently malleableto be able to open up to allow the system to achieve maximum range ofmotion without tearing the drape.

FIG. 11J shows PSM drape 404 over a portion of PSM arm 417 and a sterileadaptor 406 in place prior to strips 416 being bent back by the user.FIG. 11K shows strips 416 after being bent back by the user such thatPSM drape 404 more closely fits the shape of the PSM arm, therebyreducing the size of the system. FIG. 11L shows another view of thestrips 416 which are pliable enough to be opened for maximum range ofmotion and which can be reshaped by the user as desired during theprocedure.

Drapes 200, 300, and 400 described above are preferably comprised ofmaterial of sufficient rigidity and strength to allow proper placementover a monitor and monitor mount, an ECM arm, and a PSM arm,respectively, and to resist tearing even under application of cyclicalloads in various directions, but are preferably comprised of material ofsufficient flexibility to allow movement with the active sections of themanipulator arms. Drapes 200, 300, and 400 may be comprised of variousdurable materials, and in one example is comprised of polyethylene,polyurethane, polycarbonate, or mixtures thereof. In one embodiment,drapes 200, 300, and 400 can be vacuum formed as part of a single drapeor as separate drapes that can be attached to the main sterile drape 70via adhesive, heat, RF welding, or other means. In another embodiment,drapes 200, 300, and 400 may be used as disconnected drapes (butpossibly adjacent to one another or with overlap) to cover differentportions of the surgical robot system.

Advantageously, the drapes of the present invention increasevisualization of the patient by reducing the size of the drapes withmore form fitting features, allow for quick and simple installation, andimprove the instrument sterile adaptor feature. The drapes of thepresent invention also maintain the sterility of a monitor screen, inparticular a touch screen monitor, allow for sound to be transmitted toa microphone on the monitor drape while maintaining sterility, andreduce glare and wrinkles of the drape in front of the monitor screen.

Embodiments described above illustrate but do not limit the invention.It should also be understood that numerous modifications and variationsare possible in accordance with the principles of the present invention.For example, although drapes for particular parts of the roboticsurgical system are described in the embodiments above, other shapes andcavities for receiving other surgical system parts are within the scopeof the present invention. Accordingly, the scope of the invention isdefined only by the following claims.

1. A sterile drape to cover a non-sterile portion of a robotic surgicalsystem, the sterile drape comprising: an exterior surface adjacent to asterile field for performing a surgical procedure; an interior surfaceforming a cavity for receiving the non-sterile portion of the roboticsurgical system; an integral cuff including a permanently turned-up foldof the exterior and interior surfaces at an open end of the cavity and amarker on the permanently turned-up fold designating a sterile side anda non-sterile side of the drape; and a fastener coupled to the exteriorsurface for securing the sterile drape to the non-sterile portion of therobotic surgical system for reducing the volume of the cavity formed bythe sterile drape.
 2. The sterile drape of claim 1, wherein the exteriorsurface includes a peel-and-stick patch.
 3. The sterile drape of claim1, wherein the drape is comprised of a material selected from the groupconsisting of polyethylene, polyurethane, and polycarbonate.
 4. Thesterile drape of claim 1, wherein the cavity receives the non-sterileportion of the robotic surgical system selected from the groupconsisting of a monitor, a manipulator arm, and an endoscope cameramanipulator arm.
 5. The sterile drape of claim 1, wherein the exteriorsurface and the interior surface of the drape is couplable to anotherdrape portion.
 6. The sterile drape of claim 1, wherein the fastenerincludes malleable strips and straps.
 7. The sterile drape of claim 1,wherein the exterior and interior surfaces include a window forpositioning adjacent to a monitor screen.
 8. The sterile drape of claim7, wherein the window has a static charge.
 9. The sterile drape of claim1, wherein the exterior and interior surfaces include an instrumentsterile adaptor for engaging a surgical tool and the non-sterile portionof the robotic surgical system, the sterile adaptor being configured totransfer signals between the surgical tool and the non-sterile portionof the robotic surgical system.
 10. The sterile drape of claim 1,wherein the exterior and interior surfaces include a venting portion.11. The sterile drape of claim 1, wherein the open end further includesa purse string.
 12. The sterile drape of claim 1, wherein the open endfurther includes a tear strip.
 13. The sterile drape of claim 1, whereinthe integral cuff includes a visual marker.
 14. A sterile drapecomprising: an exterior surface adjacent to a sterile field forperforming a surgical procedure; an interior surface forming a cavityfor receiving a manipulator arm of a robotic surgical system; anintegral cuff including a permanently turned-up fold of the exterior andinterior surfaces at an open end of the cavity and a marker on thepermanently turned-up fold designating a sterile side and a non-sterileside of the drape; and a plurality of fasteners on the exterior surfacefor securing the sterile drape to the manipulator arm.
 15. The drape ofclaim 14, wherein the exterior surface includes a peel-and-stick patch.16. The drape of claim 14, wherein the exterior and interior surfacesare comprised of a material selected from the group consisting ofpolyethylene, polyurethane, and polycarbonate.
 17. The drape of claim14, wherein the plurality of fasteners include malleable strips andstraps.
 18. The drape of claim 14, wherein the exterior and interiorsurfaces include a window for positioning adjacent to a monitor screen.19. The drape of claim 18, wherein the window has a static charge. 20.The drape of claim 14, wherein the exterior and interior surfacesinclude an instrument sterile adaptor, the sterile adaptor beingconfigured to transfer signals between a surgical tool and themanipulator arm of the robotic surgical system.
 21. The drape of claim14, wherein the exterior and interior surfaces include a ventingportion.
 22. A method of draping a robotic surgical system, the methodcomprising: providing a sterile drape including: an exterior surfaceadjacent to a sterile field for performing a surgical procedure; aninterior surface forming a cavity for receiving a non-sterile portion ofthe robotic surgical system; an integral cuff including a permanentlyturned-up fold of the exterior and interior surfaces at an open end ofthe cavity and a marker on the permanently turned-up fold designating asterile side and a non-sterile side of the drape; and a fastener forsecuring the sterile drape to the non-sterile portion of the roboticsurgical system; positioning the open end at a portion of the roboticsurgical system; holding the integral cuff to unfold the sterile drapeover the portion of the robotic surgical system; and securing thesterile drape to the portion of the robotic surgical system using thefastener.
 23. The method of claim 22, further comprising coupling aninstrument sterile adaptor integrated with the sterile drape to amanipulator arm of the robotic surgical system.
 24. The method of claim22, further comprising positioning a window and a venting portion of thesterile drape proximate a monitor of the robotic surgical system. 25.The method of claim 24, further comprising unfolding the sterile drapesuch that the window is not creased or folded.
 26. The method of claim24, wherein the window is positioned adjacent to a monitor screen viastatic charge.